Trial · NCT03710642
Prazosin for Agitation in Alzheimer's Disease
NCT03710642, Phase 2, Completed, Alzheimer's Disease Cooperative Study (ADCS); results first posted 2023-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prazosin for Agitation in Alzheimer's Disease. Trials, record NCT03710642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03710642
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prazosin for Agitation in Alzheimer's Disease
- NCT number
- NCT03710642
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Alzheimer's Disease Cooperative Study (ADCS)
- Conditions
- Alzheimer's Disease, Disruptive Behavior
- Interventions
- Prazosin, Placebo oral capsule
- First posted
- 2018-10-18
- Last updated
- 2023-02-06
- Results first posted
- 2023-02-06
- Limitations and caveats
Following COVID-19, it became clear that it would not be possible to recruit the target sample size of 186 participants exclusively at LTC facilities. In 2021 we adjusted the trial size and incorporated the goal of gathering pilot data to demonstrate the feasibility of enrolling home dwelling participants and using remote visits. These changes resulted in the study sample size being re-estimated. Final enrollment was 35 randomized participants, of which 32 were at home with full time caregiving.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ADCS-Clinical Global Impression of Change in Agitation (ADCS-CGIC-A) | From Baseline through Week 12. | The ADCS-CGIC-A is the primary outcome measure. It will be anchored to disruptive agitation, the target behaviors in this study. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a direct examination of the participant and an interview of the participant's primary caregiver and other LTC facility staff. The baseline assessment is qualitative therefore there is no score at baseline; post-baseline scores represent a change score compared to baseline. The ADCS-CGIC-A is a 7-point scale that is structured as the clinician's assessment of change from baseline compared to the ADCS-CGIC-A Baseline Worksheet. There is no baseline score; post-baseline scores range from 1 (improvement) to 7 (worsening). A score of 1-2 indicates clinically meaningful improvement; a score of 3-5 indicates no clinically meaningful change; a score of 6-7 indicates clinically meaningful worsening. |
| Secondary | Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home Version (NPI-NH) | 12 weeks | The NPI was designed to characterize the neuropsychiatric symptoms and psychopathology of patients with AD and other dementias residing in the community about which information was obtained from family caregivers. The content of the questions and their scoring in the NPI-NH are identical to those of the NPI except for some slight rephrasing to be consistent with the LTC environment where information is gathered from professional caregivers. Assessment of the impact of behavioral disturbances on family and professional caregivers, is assessed by a caregiver distress scale in the NPI and an occupational disruptiveness scale in the NPI-NH; scoring of this component remains identical. Minimum score is 0 and highest score is 144. A higher score means a worse outcome. This outcome is the change from baseline to week 12. |
| Secondary | Rescue Medication: Total mg Lorazepam Administered | 12 weeks | Cumulative total dose of Lorazepam rescue medication administered during the trial. Information on the total mg rescue lorazepam administered will be collected as additional secondary outcome measures. If prazosin is more effective than placebo, it is predicted that participants randomized to prazosin will be prescribed lower cumulative mg of rescue lorazepam for management of persistent or worsening disruptive agitation. |
| Secondary | Study Discontinuations | 12 weeks | Cox proportional hazard modelling comparing the median time to drop out between treatment groups. |
| Secondary | Responder Analysis on CGIC-A | 12 weeks | Comparison of proportions of responders versus non responders on the ADCS-CGIC-A. Responders are defined as those with moderate or marked improvement in agitation symptoms compared to baseline assessment. |
| Secondary | ADCS-ADL-Severe | 12 weeks | The ADCS-ADL-Severe questionnaire is a secondary outcome measure aimed at detecting functional decline in people with severe AD. This scale is best suited for evaluating people with MMSE scores below 15/30, or equivalent. Questions are administered to a qualified caregiver informant about a set of 19 basic and instrumental ADL. Instrumental ADL are selected to be relevant to this level of severity of dementia, e.g., obtaining a beverage, turning lights on and off, turning a faucet on and off. Performance of each of these activities during the past 4 weeks, as well as the level of performance, are rated. A total score is derived by summing scores across items, and ranges from 0 (maximal impairment) to 54 (maximally independent function). This outcome is the change from baseline to week 12. |
| Secondary | Caregiver Distress on NPI/NPI-NH | 12 weeks | Comparison of effects on caregiver distress/occupational disruptiveness scores on the NPI/NPI-NH. Minimum score is 0 and maximum score is 60. A higher score is a worse outcome. This outcome is the change from baseline to week 12. |
| Other | Cohen Mansfield Agitation Inventory (CMAI). | 12 weeks | The CMAI is an exploratory outcome measure for estimating frequency of agitated behaviors. The CMAI assesses the frequency of agitated behaviors in elderly persons and was developed for use in the LTC facility. The CMAI rates 29 agitated behaviors, each on a 7-point scale (1-7) of frequency ranging from never to several times per hour. Ratings pertain to the 2-week period preceding the rating. A higher score means a worse outcome. |
| Other | Five-domain NPI/NPI-NH Subset Score | 12 weeks | The Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home version (NPI-NH) subset score includes agitation/aggression, anxiety, disinhibition, irritability/lability and aberrant motor activity. Minimum and maximum values are 0 and 60 respectively. A higher score is a worse outcome. |
| Other | Sleep Continuity | 12 weeks | Actigraphy measures of locomotor activity during the night will be compared between groups. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ADCS-Clinical Global Impression of Change in Agitation (ADCS-CGIC-A) | From Baseline through Week 12. | The population analyzed for this outcome includes: 20 study completers, and 3 early terminations that completed their termination visit at or after the week 10 timepoint. Therefore, the N analyzed is higher than the numbers of completers listed in the participant flow section. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home Version (NPI-NH) | 12 weeks | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Rescue Medication: Total mg Lorazepam Administered | 12 weeks | mg | MEAN | |
| SECONDARY | Study Discontinuations | 12 weeks | days | MEDIAN | |
| SECONDARY | Responder Analysis on CGIC-A | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ADCS-ADL-Severe | 12 weeks | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Caregiver Distress on NPI/NPI-NH | 12 weeks | score on a scale | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Cohen Mansfield Agitation Inventory (CMAI). | 12 weeks | |||
| OTHER_PRE_SPECIFIED | Five-domain NPI/NPI-NH Subset Score | 12 weeks | |||
| OTHER_PRE_SPECIFIED | Sleep Continuity | 12 weeks |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ADCS-Clinical Global Impression of Change in Agitation (ADCS-CGIC-A) | Treatment (Prazosin) | 3.434 | Standard Error 0.2833 | score on a scale | |
| ADCS-Clinical Global Impression of Change in Agitation (ADCS-CGIC-A) | Placebo Oral Capsule | 3.442 | Standard Error 0.6141 | score on a scale | |
| Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home Version (NPI-NH) | Treatment (Prazosin) | -6.033 | Standard Error 4.692 | units on a scale | |
| Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home Version (NPI-NH) | Placebo Oral Capsule | 5.506 | Standard Error 10.149 | units on a scale | |
| Rescue Medication: Total mg Lorazepam Administered | Treatment (Prazosin) | 0.25 | Standard Deviation 0.69 | mg | |
| Rescue Medication: Total mg Lorazepam Administered | Placebo Oral Capsule | 0.14 | Standard Deviation 0.24 | mg | |
| Study Discontinuations | Treatment (Prazosin) | 65.63 | Standard Deviation 32.63 | days | |
| Study Discontinuations | Placebo Oral Capsule | 54.62 | Standard Deviation 33.29 | days | |
| Responder Analysis on CGIC-A | Treatment (Prazosin) | 7 | Participants | ||
| Responder Analysis on CGIC-A | Placebo Oral Capsule | 1 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Prazosin) | 27 | |
| Overall Study | STARTED | Placebo Oral Capsule | 8 | |
| Overall Study | COMPLETED | Treatment (Prazosin) | 17 | |
| Overall Study | COMPLETED | Placebo Oral Capsule | 3 | |
| Overall Study | NOT COMPLETED | Treatment (Prazosin) | 10 | |
| Overall Study | NOT COMPLETED | Placebo Oral Capsule | 5 |
Source ClinicalTrials.gov
Adverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bradycardia | Cardiac disorders | Treatment (Prazosin) | 2 | 26 | |
| other | Bradycardia | Cardiac disorders | Placebo Oral Capsule | 1 | 8 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Treatment (Prazosin) | 1 | 26 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo Oral Capsule | 0 | 8 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Treatment (Prazosin) | 1 | 26 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo Oral Capsule | 0 | 8 | |
| other | Ecchymosis | Skin and subcutaneous tissue disorders | Treatment (Prazosin) | 1 | 26 | |
| other | Ecchymosis | Skin and subcutaneous tissue disorders | Placebo Oral Capsule | 0 | 8 | |
| other | Cardiac Failure | Cardiac disorders | Treatment (Prazosin) | 1 | 26 | |
| other | Cardiac Failure | Cardiac disorders | Placebo Oral Capsule | 0 | 8 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Prazosin) | 0 | 26 |
| Total, all-cause mortality | Placebo Oral Capsule | 0 | 8 |
| Total, other adverse events | Treatment (Prazosin) | 13 | 26 |
| Total, other adverse events | Placebo Oral Capsule | 4 | 8 |
| Total, serious adverse events | Treatment (Prazosin) | 5 | 26 |
| Total, serious adverse events | Placebo Oral Capsule | 0 | 8 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U19AG010483 | Alzheimer's Disease Cooperative Study | FELDMAN, HOWARD | UNIVERSITY OF CALIFORNIA, SAN DIEGO | NATIONAL INSTITUTE ON AGING | 2013 to 2020 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment (Prazosin) vs Placebo Oral Capsule: Responder Analysis on CGIC-A | Trial comparisons |
| Treatment (Prazosin) vs Placebo Oral Capsule: deaths from any cause | Trial comparisons |
| Treatment (Prazosin) vs Placebo Oral Capsule: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03710642
GET https://conductscience.org/api/trials/v1/NCT03710642/events?page=2